HIV Infections Clinical Trial
Official title:
Delaying HIV Disease Progression With Punctuated Antiretroviral Therapy in HIV-Associated Tuberculosis
This study is designed to determine whether 6 months of anti-HIV drugs given along with tuberculosis treatment will delay the onset of AIDS in HIV infected African patients.
Tuberculosis (TB) is a common and serious complication of HIV infection in the developing
world, especially in sub-Saharan Africa. Since the emergence of the HIV epidemic in Africa,
the incidence rates of TB have risen dramatically, overwhelming national TB control programs
across the continent. Over 50% of TB patients presenting to TB clinics in Africa are HIV
infected. These patients often present in the early stages of HIV infection.
Recent World Health Organization guidelines on the management of HIV-associated pulmonary TB
recommend antiretroviral (ARV) therapy in patients with CD4 cells less than 200 cells/mm3,
but not for HIV infected TB patients who present with a high CD4 count. In Uganda, over half
of HIV infected patients with active TB present to TB clinics with CD4 counts above 200
cells/mm3, and there is evidence that coinfected patients with a high CD4 count should be
treated with ARV therapy. First, mortality in HIV-associated TB is high, even when patients
respond to effective anti-tuberculosis therapy. Second, excess mortality associated with TB
is most evident when CD4 counts are above 200 cell/mm3. Third, in coinfected patients, TB
results in prolonged immune activation, which may enhance viral replication and accelerate
the decline of CD4 cells.
This study will evaluate whether short-term ARV therapy of abacavir sulfate, lamivudine, and
zidovudine given during treatment of active TB will slow progression of HIV disease in TB
patients with CD4 counts of at least 350 cells/mm3. The study will also assess the possible
risks (e.g., drug toxicities and resistance) and benefits (e.g., more rapid clearance of
mycobacterium tuberculosis and reduced TB relapse) of punctuated ARV therapy.
Participants in this study will be HIV infected TB patients with CD4 counts of at least 350
cells/mm3. All participants will receive treatment for TB. Participants will be randomly
assigned to receive 6 months of ARV therapy or to delay ARV therapy until CD4 counts drop
below 250 cells/mm3. The participants will be followed for 2 years; CD4 counts will be
compared between groups.
This study will also follow a group of HIV infected patients without active TB to quantify
the extent to which CD4 cell decline is accelerated with active TB and to determine the
extent to which a decline is neutralized in patients who receive punctuated ARV therapy.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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